IV Infusion/Bolus Pk normalisation [Dissolution / BCS / IVIVC]

posted by pharm07 – India, 2021-06-24 07:48 (92 d 03:32 ago) – Posting: # 22432
Views: 421

» Usually AUC is the parameter you can compare, if you are looking to generate absolute bioavailability details. However, your dose selection depends upon the bioavailability of extravascular administration.
» However, I dont understand the selection of IV lower strength and oral higher strength. Do you have any correlation on data?

Hi, Thanks for your inputs.

To be very specific, if i need to validate the predicted p.o. profile from IV Infusion which is a lower dose than oral, then how to scaleup pk parameter to validate oral predictive profile?

For eg, I have IV infusion 10 mg and i wanted to validate the 80mg oral.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]


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